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Phase II Study for Patients With Relapsed Primary Central Nervous System Lymphoma
This study is currently recruiting participants.
Verified by Ohio State University Comprehensive Cancer Center, December 2006
Sponsored by: Ohio State University Comprehensive Cancer Center
Information provided by: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00261651
  Purpose

This study will evaluate the efficacy of combination chemotherapy plus reversible opening of the blood brain barrier in recurrent primary central nervous system lymphoma. Cognitive function, neurotoxicity, quality of life, and other side effects will also be assessed in this patient population.


Condition Intervention Phase
Lymphoma
Drug: rituximab
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: cytarabine
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Cyclophosphamide Carboplatin Cytarabine Cytarabine hydrochloride Etoposide Rituximab Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Phase II Study for Patients With Relapsed Primary Central Nervous System Lymphoma

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • To evaluate efficacy of chemotherapy regimen.

Secondary Outcome Measures:
  • Overall survival
  • 2 year progression free survival
  • Quality of life
  • Cognitive function
  • Neurotoxicity
  • Ototoxicity
  • Effect of delayed sodium thiosulfate on granulocyte and erythrocyte counts
  • Polymerase chain reaction examination of csf

Detailed Description:

Rationale: The blood brain barrier is made up of tightly packed cells to protect the brain from toxic materials that might travel up from other parts of the body. However, the blood brain barrier also blocks the delivery of drugs, including therapies for brain tumors. This study includes a combination of chemotherapy agents that might have efficacy against malignant central nervous system lymphoma and a technique called reversible opening of the blood brain barrier. The technique is experimental and might improve the delivery of treatments to the disease in the brain. Through this technique, the blood brain barrier is opened during an angiogram, or blood vessel study of the brain, along with the use of other substances.

Treatment: Patients in this study will receive the following treatments: rituximab (Rituxan), carboplatin (Paraplatin), cyclophosphamide (Cytoxan), etoposide phosphate (Etopophos), and cytarabine (Cytosar-U). A technique called reversible opening of the blood brain barrier will also be performed in patients. For two successive days each month for 12 to 16 months, patients will be admitted to the hospital to receive study treatments and an angiogram. The night before the angiogram, patients will receive rituximab through an intravenous infusion. The next day, an angiogram will be performed with a general anesthetic and catheter placed in an artery in the groin. The catheter will be directed into the neck to one of the arteries going to the brain that supplies the tumor area. A sugar concentration will then be given to open up the blood brain barrier.

During the two days in the hospital, the drugs carboplatin, cyclophosphamide, and etoposide phosphate will be given to patients. An imaging exam will be performed before opening the blood brain barrier and during the angiogram to assess the amount of blood brain barrier opening. At the physician's discretion, patients may undergo chemotherapy without opening the blood brain barrier due to safety issues. Two weeks after the hospital chemotherapy, patients will receive the drug cytarabine. This agent will be given into spinal fluid through a spinal tap or Ommaya reservoir, which is a port that is implanted under the scalp.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Central nervous system (CNS) lymphoma
  • CD20 positive

Exclusion Criteria:

  • Pregnant or Nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261651

Contacts
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: John McGregor Ohio State University
  More Information

Study ID Numbers: OSU-0329
Study First Received: December 1, 2005
Last Updated: December 26, 2006
ClinicalTrials.gov Identifier: NCT00261651  
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Central Nervous System

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Carboplatin
Cyclophosphamide
Lymphoproliferative Disorders
Etoposide phosphate
Etoposide
Lymphoma
Cytarabine
Central nervous system lymphoma, primary

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009